5 Pa­tient En­gage­ment & Re­cruit­ment Trends, and How to Keep Up with Them

Some trends come and go, and some are here to stay. We’ll take a look at five top trends shap­ing the phar­ma­ceu­ti­cal in­dus­try and as­sess their ef­fect on pa­tient en­gage­ment and re­cruit­ment.

Trend 1: De­cen­tral­ized & hy­brid tri­als

The ad­vent of COVID-19 changed the way clin­i­cal tri­als are con­duct­ed, mov­ing from site-cen­tered re­search to de­cen­tral­ized tri­als (DCTs) and hy­brid op­tions. How­ev­er, as the study ref­er­enced be­low in­di­cates, re­sis­tance to change and man­ag­ing mul­ti­ple ven­dors are among the top five hur­dles to im­ple­ment­ing these non-tra­di­tion­al tri­als.

A study by The Tufts Cen­ter for the Study of Drug De­vel­op­ment (Tufts CS­DD) ex­am­ined the im­pact of both de­cen­tral­ized and hy­brid tri­als on col­lab­o­ra­tions be­tween spon­sors and con­tract re­search or­ga­ni­za­tions (CROs)/clin­i­cal re­search as­so­ciates (CRAs). Ac­cord­ing to the study, CROs and ven­dors al­so cit­ed main bar­ri­ers to im­ple­men­ta­tion of DCT and hy­brid tri­als as coun­try chal­lenges, var­ied site ca­pa­bil­i­ties with re­spect to nov­el tech­nolo­gies, and da­ta col­lec­tion.

The De­cen­tral­ized Tri­als and Re­search Al­liance (DTRA) al­so has iden­ti­fied bar­ri­ers to DCT adop­tion and pro­motes col­lab­o­ra­tion as a way to coun­ter­act them:

• Re­mov­ing siloed ap­proach­es with stan­dard­ized mod­els and KPIs
• Shar­ing best prac­tices to re­duce risk and im­prove out­comes
• Gath­er­ing da­ta from across the clin­i­cal tri­al com­mu­ni­ty to pro­vide ed­u­ca­tion­al re­sources for all stake­hold­ers

It’s im­por­tant for spon­sors to ed­u­cate pa­tients about the op­por­tu­ni­ties that DCTs rep­re­sent, and they al­so must seek out part­ners open to new ways of con­duct­ing clin­i­cal tri­als. Con­verse­ly, po­ten­tial DCT part­ners must ad­e­quate­ly com­mu­ni­cate their strengths and how they can ease the bur­den both for spon­sors and site staff.

Trend 2: Post-COVID adop­tion of tech­nol­o­gy

Go­ing hand in hand with DCTs is the in­creased use of tech­nol­o­gy. While DCTs may not nec­es­sar­i­ly be ful­ly re­mote, vir­tu­al or site-less tri­als take the con­cept to a whole new lev­el. And with that flex­i­bil­i­ty comes the tech­nol­o­gy need­ed to pull it off.

New tech­nol­o­gy of­ten cre­ates new headaches for users. A So­ci­ety for Clin­i­cal Re­search Sites (SCRS) sur­vey re­vealed that tech­nol­o­gy adds an av­er­age of 17.5 hours in train­ing per study per site per month; one prin­ci­pal in­ves­ti­ga­tor (PI) re­port­ed hav­ing more than 300 unique pass­words and lo­gins. Some clin­i­cal re­search co­or­di­na­tors (CRCs) re­port us­ing eight or more sys­tems for each study as­signed.

Since spon­sors can’t es­cape the ex­plo­sion of tech­nol­o­gy sur­round­ing tri­als, they should sur­round them­selves with ven­dors that can talk the talk and walk the walk. Just as it’s im­por­tant for spon­sors to use plain lan­guage when shar­ing clin­i­cal tri­al de­tails with pa­tients, tech ven­dors must sim­pli­fy terms when ex­plain­ing their ser­vices. The goal is to avoid the glazed-eyes re­sponse that of­ten comes with the ter­ri­to­ry.

Trend 3: Pa­tient cen­tric­i­ty

This trend has been around for quite some time, but on­ly re­cent­ly has it be­gun to be ac­tion­al­ized by the phar­ma­ceu­ti­cal com­mu­ni­ty. Com­mu­ni­ca­tion is key to pa­tient cen­tric­i­ty be­fore, dur­ing and af­ter the clin­i­cal tri­al. Main­tain­ing com­mu­ni­ca­tion is on­ly part of the an­swer; con­sis­tent com­mu­ni­ca­tion makes par­tic­i­pants feel in the loop and val­ued. Of course, the com­mu­ni­ca­tion it­self must be rel­e­vant, and how the mes­sage is de­liv­ered can­not be over­looked. Is it easy to un­der­stand? Is it in a for­mat that’s ac­ces­si­ble?

Tri­al par­tic­i­pants must be treat­ed like in­di­vid­u­als, not “sub­jects.” In fact, the phar­ma in­dus­try has, for­tu­nate­ly, moved away from that ver­biage when re­fer­ring to study par­tic­i­pants.

When spon­sors go through the ven­dor vet­ting process, check­ing off must-haves, pa­tient cen­tric­i­ty should be to­ward the top of the list. Ven­dors should be pre­pared to pro­vide ex­am­ples, such as cus­tomer or pa­tient tes­ti­mo­ni­als, that re­flect their pri­or­i­ti­za­tion of and com­mit­ment to pa­tients.

Trend 4: Clin­i­cal tri­al di­ver­si­ty

We couldn’t talk about drug de­vel­op­ment trends with­out men­tion­ing clin­i­cal tri­al di­ver­si­ty. The sta­tis­tics say it all. Cen­sus fig­ures from 2021 show that eth­nic and racial mi­nori­ties com­prise over 40 per­cent of the U.S. pop­u­la­tion; how­ev­er, ac­cord­ing to the Fed­er­al Drug Ad­min­is­tra­tion’s (FDA) 2022 da­ta snap­shot on di­ver­si­ty and in­clu­sion among clin­i­cal tri­als, whites com­prised the ma­jor­i­ty of pa­tients en­rolled in clin­i­cal tri­als.

This rep­re­sents a chal­lenge―and an op­por­tu­ni­ty―for study spon­sors to lev­el the play­ing field, so to speak. And the di­ver­si­ty dilem­ma is not lim­it­ed to the U.S.; it is a glob­al prob­lem.

Grass­roots ef­forts have proved suc­cess­ful in en­cour­ag­ing those from mi­nor­i­ty pop­u­la­tions to en­roll in clin­i­cal tri­als. Dis­ease sup­port groups al­so are a good way to reach these in­di­vid­u­als, as they have es­tab­lished trust, which is cru­cial to over­com­ing hes­i­tan­cy to par­tic­i­pate.

Trend 5: In­creased use of re­al-world da­ta (RWD)

Every­where you turn in the phar­ma world, you run in­to the phrase “re­al-world da­ta,” and pa­tient en­gage­ment/re­cruit­ment is no ex­cep­tion. The Clin­i­cal Tri­als Trans­for­ma­tion Ini­tia­tive (CT­TI), a pub­lic–pri­vate part­ner­ship co­found­ed by Duke Uni­ver­si­ty and the FDA, has is­sued rec­om­men­da­tions on us­ing RWD in set­ting el­i­gi­bil­i­ty cri­te­ria and en­hanc­ing re­cruit­ment:

While RWD ex­pands op­por­tu­ni­ties for pa­tient re­cruit­ment, it must be used with cau­tion. Pro­ce­dures should be in place to pro­tect sen­si­tive da­ta and en­sure pa­tient pri­va­cy.

The use of RWD is most ef­fec­tive when it is drawn from a va­ri­ety of sources. Like­wise, be­fore em­bark­ing on the use of RWD for re­cruit­ment, spon­sors should en­gage with a full range of stake­hold­ers, from pa­tients to in­sti­tu­tions and in­sti­tu­tion­al re­view boards (IRBs). Po­ten­tial re­cruit­ment part­ners are wise to alert spon­sors to the val­ue of their own datasets.

Un­pack­ing the im­pact

In ad­dress­ing the is­sues raised by these trends, the onus is not sole­ly on spon­sors. All stake­hold­ers would be well ad­vised to cap­i­tal­ize on the ben­e­fits of col­lab­o­ra­tion. As the say­ing goes, “it takes a vil­lage” — this ap­plies to the clin­i­cal tri­als realm more so than ever. Con­nect­ing with a va­ri­ety of part­ners in­creas­es reach for both spon­sors and part­ners alike. While work­ing with new part­ners may light­en the load for over­worked site staff, there’s still the task of man­ag­ing mul­ti­ple part­ners. This is par­tic­u­lar­ly true in terms of pa­tient en­gage­ment and re­cruit­ment, which is why a sin­gle plat­form such as Cite­line Con­nect can con­sol­i­date ef­forts, mak­ing the whole process ex­ceed­ing­ly more man­age­able.